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Comparison of Two Treatments in Intermediate and High-risk Acute Promyelocytic Leukemia (APL) Patients to Assess Efficacy in 1st Hematological Complete Remission and Molecular Remission

Last updated on March 14, 2019

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Study Location
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1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Myelocytic Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-61 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Patients with untreated newly diagnosed and genetically proven APL (leukemic cells at
diagnosis with the t(15;17) and/or the PML/RARα rearrangement by RT-PCR; the presence
of additional cytogenetic lesions is not considered an exclusion criterion) with
intermediate and high risk disease.

2. Male and female patients age > 18 years and

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Low risk patients (WBC 40 x 109/L).

2. Absence of PML-RAR ? rearrangement in leukemic cells after successful RNA extraction
and amplification of control gene.

3. Pretreated APL.

NCT00962767
Pfizer
Completed
Comparison of Two Treatments in Intermediate and High-risk Acute Promyelocytic Leukemia (APL) Patients to Assess Efficacy in 1st Hematological Complete Remission and Molecular Remission

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